Clinical Trials and Research News Weekly Roundup | 6-29-2019 S1 E2



welcome to trial site news weekly round-up my name is Adrian and I'll be going over some of that Matata news stories from this past week please click the subscribe button and ring the bell to be notified of future videos this week we start off our roundup with drug and patient exploitation alerts a common prescription medicine has been linked to an almost 50% higher chance of getting dementia according to the University of Nottingham a uk-based study the University of Nottingham led the study focused on diagnosis data for two hundred and eighty four thousand three hundred and forty three individuals over 55 that were registered with GPS in the United Kingdom nearly fifty nine thousand of the individual study word diagnosed with dementia at some point the Nottingham investigators found that within eleven years according to their dementia diagnosis fifty six point six percent of the patients or 33 thousand two hundred and fifty three had been prescribed anticholinergic drugs those individuals in the UK that were on antidepressants and he Parkinson's drugs antipsychotics and people epic drugs and those that used to control bladder incontinence experienced greater risk which could be considered by some a striking situation professor Tom demean noted that this study provides further evidence that doctors should be careful when prescribing certain drugs that have anticholinergic properties he however cautioned patients to not just stop taking the drugs they must go to see a doctor and consider the options first in other related news boston-based Dana Farber Cancer Institute is seeking a share of the 1.6 billion dollars in licensing revenue that bristol-myers Squibb or BMS and on a pharmaceutical company have allegedly received from six immunotherapy patents that a court recently ruled is partially Dana farmers Dana Farber core claimed that the dual unfairly deprived the Cancer Center of the opportunity to grant royalty bearing licenses and at the center of licensing revenue now we have been studying many preclinical licensing deals universities are in many cases giving industry sponsors really good deals for potentially valuable intellectual property access we think in many cases they are under charging industry sponsors and we at trial site News wonder if they will start to extract a Grady a greater premium on their intellectual capital now on to trial monitoring related news global cr.lp Rexel has inked a deal with Clare Ness combining that company's clean life patient portal and its own regional expertise about China's research centres in patient population in an effort to more effectively recruit and retain clinical trial patients in China reports IBM magazine the partnerships seeks to leverage digital technologies and per excells CRO based regional expertise to improve recruitment the fact that China has over 770 million Internet users which represents double that of the u.s. population will helping recruitment clarinets turn key patient portal tool is available in more than 28 languages and in 42 countries including China for many drug developers China represents a mission-critical market it is barely penetrated by Western biopharmaceutical companies in terms of drug product revenue and market share we look forward to seeing what this partnership may bring in other trial monitoring news the Association for the accreditation of human research protection programs or the aah our PP reports that it has accredited three more research organizations including a first in the Middle Eastern country of Jordan the three newly accredited research sites include Intermountain Healthcare and Murray Utah King Hussein Cancer Center in Amman Jordan the University of Texas Southwestern Medical Center in Dallas Texas now accreditation is vitally important for research sites it represents a commitment to quality and safety for human participants in clinical research as in the case of the aah or PP moving on now to autoimmune related news a report from researchers led by Penn State Milton s Hershey Medical Center in pencil Vania let us study investigating the relationship between Hydra nidus support iva HS and alopecia areata in aus sample revealed those with HS had a significantly higher risk for alopecia and also like in pl'anna pilaris this means that hair loss and associated scarring could be associated with the condition lead researcher Jocelyn s Kirby and D ms head of the department of dermatology at Penn State reported that both alopecia areata and HS likely involve an itching event at the hair follicle which leads to subsequent inflammation stated avigal Sutton of Helio we have heard from several of our HS readers that they have noticed hair loss and are glad that this research is being done elsewhere in exciting news for those that seek autoimmune disease cures three Penn investigators have received a 4.5 million dollar grant to establish a clinical Center researching autoimmune diseases the new Center is called an autoimmunity Center of Excellence or ace and is the fifth of its kind in the United States this Center will include two clinical trials as well as a collaborative project with other a centers Penn's ace will include dermatology neurology and pathology researchers to focus on the role of b-cells in autoimmune disease the grant itself originates on the National Institute of Allergy and Infectious Diseases which is part of the NIH and will allow Penn professors to study human participants rather than just patient samples dr. Amy Paine an associate professor of dermatology will serve as the Penn ace administrative director continuing on with autoimmune related news the Oklahoma Medical Research Foundation receive a 3.1 million dollar grant to study more about lupus with the hopes of finding a way to beat it someday the Oklahoma Medical Research Foundation or the OU MRF will utilize recent funding to see if we can find a mechanism or pathway that could eventually be targeted by therapy or treatment quoted dr. Patrick Gaffney a scientist at the OM or F o MRF is a venerable institution Oklahoma and beyond launching just after World War Two in 1946 they have since contributed significantly to medical research om RF research has led to things like zai Gris the first fda-approved drug for the treatment of sepsis and supportin a therapy for people suffering from a rare and life-threatening blood disorder known as a protein C deficiency research at om RF also identify the enzyme believed responsible for Alzheimer's disease and laid the groundwork for uncle view a breast cancer assessment test now trial site News has reported extensively about ex biotechs quest to cure Hydra not a separate Eva our readers struggling with this particular disease will be happy to know that Alice Gottlieb MD PhD will chair the company's upcoming Phase two bro Mecca mAb clinical trial she is the medical director of dermatology at the Mount Sinai Beth Israel campus and clinical professor at ICANN School of Medicine at Mount Sinai she is one of the few physicians in the nation board-certified in dermatology Rheumatology and eternal medicine dr. Gotlieb commented we need more effective treatment for Hydra NIDA separate Eva from ekam AB offers that potential option for a more effective treatment for HS ex biotechs president and CEO Johnson Lord commented that we are honored to have dr. Gottlieb continue to advance our bure Mecca med program NHS dr. Gottlieb chaired a recent open label study with BER Mecca map that demonstrated that weekly treatment with ver Mecca MAV was associated with statistically significant improvement in HS in a study sixty-one percent of patients with no prior biological therapy achieved positive high score or Hydra netted separate Eve a clinical response at 12 weeks while 63% of patients who had previously failed biological therapy also achieved a positive high score at the endpoint patients with no prior biological therapy had a 64 percent reduction in pain compared with baseline which those who had previously failed anti-tnf therapy or Keinath blockers had a 54% reduction in pain we are excited to see what dr. Gottlieb does in the future in other related autoimmune news preclinical researchers from Aarhus University in Aarhus University Hospital have transplanted a human immune system into mice enabling the study of immune functions which otherwise would be difficult to study the Danish preclinical research succeeded in transplanting human stem cells into mice whose own immune system is disabled amazingly the researchers triggered a type of reaction in the immune system which normally reacts to meeting a range of viruses and bacteria Anna Holling Faulkner Andersen a PhD student at the Department of Clinical medicine at Aarhus University and one of the researchers behind it the study noted that the humanized mice are an important tool in understanding how human immune cells behave during diseases and how they react to different medical treatments so being able to show that it's possible to study human steen in mice represents an important step we hope that this will lead to better research into diseases that are related to sting and quote shifting gears now to cancer related news cancer research is globalized with researchers around the world sharing and pooling data to ideas to collaboratively study a disease that kills 10 million people annually International collaborations represents a core underpinning of these programs everywhere including an intrinsic part of the u.s. national cancer institute's moonshot program Peter Waldman of bloomberg reports that the NIH and the FBI are targeting ethnic Chinese scientists including those that are US citizens searching for a cancer cure recently an award-winning epidemiologist – Wu quietly resigned from her position at the Center for Public Health and translational genomics at the University of Texas MD Anderson Cancer Center after a three-month investigation into her professional connections in China a disease such as cancer knows no borders and the cure will surely require ongoing global collaborations of the type ongoing for decades to come in further cancer related news the FDA provided a complete response letter to Titus thank you alerting them as to the reasons why the new drug application or NDA for quiz are to dip as a treatment of adults with relapsed refractory flt3 itd positive acute myeloid leukemia or AML would not be approved apparently the FDA's decision derives from the Mays 2019 recommendation from the organization's oncologic drug Advisory Committee or Leo DAC the panel voted eight to three that the available data did not definitively demonstrate that the benefit of Chris are today outweighed the potential risks quiz Arthur nebe is a small molecule receptor tyrosine kinase inhibitor originated Ampat Biosciences dr. Heidi D clippin of Wake Forest University Health Sciences noted Emma quote I voted no based on the available data the efficacy results that we were shown are modest six weeks and if I feel confident in that data that would have been enough for me in this setting of AML but a lot of the questions that were raised with respect to bias confounding and I do think the issue of equipoise or interests is a real one in the setting of this particular study it raises questions about whether or not that survival benefit is real meanwhile this month Genentech a Roche company had the drug known as Paulo to Zermatt better than Peak or pol IV approved by the Food and Drug Administration for the FDA the drug a cd79b directed antibody drug conjugate was approved for the treatment of diffuse large b-cell lymphoma or DLBCL when used in combination with venomous teen and rituximab DLBCL is considered potentially curable now Polly B represents a new powerful class of cancer fighting therapy called antibody drug conjugate or ABC Genentech license the underlying ADC technology from Seattle Genetics ABC's attacks the cancer cells in the body while avoiding healthy cell and tissue they potentially help us take our fight against cancer the next level and we look forward to more to come our final cancer related news this week is from medical research comm which recently showcased NYU Langone health investigators concerning the topics of circulating MBA NYU Langone health investigators established that several studies of metastasis have demonstrated that measuring circulating tumor DNA or CDC TDMA associates with their disease burden and survival they reported that an NYU Langone representative believes that the study provides solid evidence to support more studies to evaluate additional on treatment blood measurements to continuously improve how we determine how we may be able to benefit from these tests moving forward one reasonable hope would be that continuous monitoring of CT DNA in patients undergoing treatments for fantastic melanoma can provide an early indication of treatment failure triggering notice to doctors and health teams to consider modifying the patient's treatments or ordering radiographic scans ahead of the routine schedule we look forward to further studies regarding CT DNA and metastasis tting gears now to autism related news stories the NFL's Philadelphia Eagles are providing autism in a novel way when it comes to health-related philanthropy by selecting individual research projects for funding with the effect of turning the team into a giant founder of research the Eagles aren't just giving money away for a photo op they are strategically targeting research not just handing money over to an institution and letting them do whatever they want rather they are strategically selecting the type of research they want to fund taking an active approach in the process in this way a professional football NFL team becomes a research sponsor a fascinating trend if it continues the Philadelphia Eagles autism challenge has raised considerable sums and that number may increase over time with continued success for those interested the Philadelphia Eagles autism challenge executive director is Ryan Hammond see trial site news the Khanh for more contact information and finally we turn to Women's Health News one University researchers have spent a couple of decades working on developing a drug to combat preeclampsia and I recently completed a preclinical study published in the journal scientific reports the study was conducted in a transgenic mouse model of preeclampsia and the resulting results trigger an important discussion as they confirm studies by the same research team evidencing that alpha 1 micro globulin has potential therapeutic effects in preeclampsia senior researcher at Lena Orland ursin notes the treatment based on the human body's own scavenger protein aim or alpha 1 micro globulin which is present in all vertebrae has a good effect on the disease symptoms such as high blood pressure and protein leakage from the kidneys into the urine we also observed an improvement in organ function in the kidney and the Placentia we saw no indication of the side effects in the study now published using the preeclampsia mouse model which best reflects the various stages of the disease during pregnancy the mice developed series preeclampsia in early pregnancy now preeclampsia is a devastating event we are glad to see some headway being made on this front final notes we are excited to announce the launch about podcast starting July 10th we will be interviewing as a first guest Adam immune he will be discussing how he has been able to put his autoimmune issues in remission through food you can check out his YouTube channel below in the description and you can listen in to the podcast on July 10th at our website at trial site news.com don't forget remember to subscribe and ring the bell to be notified of updates

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